Page 195 - Safety Risk Management for Medical Devices

174 Safety Risk Management for Medical Devices

In the semiquantitative method, the comparison with the state-of-the-art is easier
than in the qualitative method, but still equivocal.

19.4 RISK EVALUATION FOR QUANTITATIVE METHOD

The BXM method uses quantitative methods for risk estimation and evaluation. In
the quantitative method as in the other methods, where possible, use compliance with
applicable international or national product safety standards as indications of
risk acceptance. Where applicable standards are not available, compare to the state-of-
the-art, or refer to benefit risk analyses.
In the quantitative method, comparison with the state-of-the-art is relatively
straight forward. Compute the residual risk for a Hazard, a Hazardous Situation, or
overall in the five severity classes of Catastrophic, Critical, Serious, Minor, and
Negligible. See Section 17.3 for a detailed explanation on how to compute risk. If
the computed residual risk for any severity class is larger than the acceptable risk limits
that are spelled out in the RMP, then the risk is not acceptable. Otherwise, the risk is
acceptable.
Just because a risk computes to be unacceptable, it doesn’t mean the medical
device cannot be released to the market. If benefit risk analysis shows that the
benefits of the device outweigh its risks, it may still be possible to get regulatory
approval for the medical device.